July 01, 2025
9 min watch
Key takeaways:
- Sufferers had a historical past of 4 or extra migraine days every month.
- Doses included 60 mg of atogepant or the utmost tolerated dose of topiramate.
- The protection profile for atogepant was just like earlier research.
Sufferers with migraine discontinued remedy much less usually with atogepant and skilled a larger discount in imply month-to-month migraine days in contrast with topiramate, in accordance with topline outcomes from a part 3 research.
“Topiramate is a broad-acting anti-epileptic treatment that’s been round for a really very long time,” Jessica Ailani, MD, director, MedStar Georgetown Headache Middle, advised Healio. “It’s truly FDA accredited to stop migraine, but it surely’s broad performing and isn’t actually migraine-specific in its mechanism of motion.”
Information derived from press launch.
Topiramate is likely one of the mostly used generic remedies for migraine prevention and has even turn into the usual of care, in accordance with Ailani.
“Most suppliers are prescribing generic remedies for prevention,” she stated.
Jessica Ailani
Atogepant (Qulipta/Aquipta, AbbVie) was particularly designed to stop migraine by blocking calcitonin gene-related peptide (CGRP) receptors, in accordance with a press launch from Abbvie.
“The principle variations are the specificity of the goal, its design in its molecule, and the illness state that it’s made for, which theoretically means it will have fewer negative effects and be extra focused in its remedy,” Ailani stated.
Ailani and her colleagues sought to check the present commonplace of care with anti-CGRP remedy.
“Taking a look at atogepant, how would sufferers tolerate this remedy, and would they keep on remedy longer? Would they’ve higher efficacy? Would sufferers not have as many negative effects?” she stated. “If a affected person tolerates a remedy and stays on remedy longer, they’re going to have higher efficacy, and that is truly actually essential.”
TEMPLE, a part 3, multicenter, randomized, double-blind, active-controlled trial, included 545 adults with a historical past of 4 or extra migraine days every month.
Trial demographics primarily included girls with a median age of their early 40s.
“It was a trial that was primarily achieved in Europe.,” Ailani stated. “A lot of the sufferers had episodic migraine, which is in step with the overall inhabitants that has migraine. The typical variety of migraine days was between 5 and 10 days a month.”
After a 6-week up-titration part, sufferers obtained 60 mg of atogepant or the utmost tolerated dose of topiramate, which ranged from 50 mg to 100 mg, every day for an 18-week upkeep interval. Eligible sufferers then continued within the research with 60 mg doses of atogepant every day for 52 weeks.
Sufferers recorded information about headache frequency, length and signs in addition to their acute treatment use and different outcomes in an digital diary.
At 24 weeks, 12.1% of the atogepant group and 29.6% of the topiramate group discontinued remedy as a consequence of antagonistic occasions, with a relative danger of 0.41 (95% CI, 0.28-0.59; P < .0001).
Additionally, 64.1% of the atogepant group and 39.3% of the topiramate group achieved a 50% or larger discount in imply month-to-month migraine days throughout months 4 to six (P < .0001).
The researchers famous that atogepant outperformed topiramate within the research’s 5 different secondary endpoints, comparable to percentages of sufferers with larger than 50% response and patient-reported outcomes, as properly.
“Traditionally, we all know that within the migraine house, most sufferers cease prevention over the course of 6 to 12 months,” Ailani stated. “Individuals typically cease prevention as a result of it’s not efficient sufficient for the kind of negative effects they’ve.”
Hostile results of topiramate can embrace weight reduction, kidney stones, modifications in style, tingling, gastrointestinal upset, lab worth abnormalities comparable to metabolic acidosis and cognitive modifications, Ailani stated.
“Individuals will usually describe word-finding difficulties or confusion,” she stated.
The researchers moreover categorized the security profile for atogepant as typically in step with earlier analysis.
“The principle aspect impact is constipation. You’ll be able to see weight discount, due to the mechanism of motion of the drug,” Ailani stated. “There’s a small portion of sufferers that may have nausea or can have somnolence, with charges lower than 3%.”
These findings spotlight the position that CGRP inhibitors have as first-line preventive remedy for migraine, as really useful by the American Headache Society and Worldwide Headache Society, AbbVie stated within the launch.
Ailani added that earlier analysis signifies that erenumab (Aimovig; Amgen, Novartis), which is one other CGRP inhibitor, has higher tolerability and efficacy in contrast with topiramate as properly.
“We noticed very related findings with higher security and tolerability,” she stated. “When you’ve medication which can be created particularly for a illness course of, the tolerability profile tends to be higher, and sufferers keep on the remedy longer. In fact, in the event that they keep on remedy, they’re going to do higher.”
Because the second-leading reason for incapacity worldwide, impacting roughly 14% of the worldwide inhabitants, migraine stays underdiagnosed and undertreated with quite a few gaps in preventive care regardless of its burden on sufferers’ lives, in accordance with the discharge.
“Take into consideration prescribing disease-specific remedies in your sufferers,” Ailani stated. “That is essential.”
The researchers will proceed to research the info earlier than publishing it in full, Ailani stated, with the purpose of getting it in entrance of well being care and insurance coverage suppliers alike. Additionally, she stated, she want to delve additional into the cognitive outcomes.
“We frequently will hear sufferers with migraine, particularly those who battle on the larger finish of 8, 10, 12 days a month, having a number of cognitive dysfunction. So, how did they do on remedy?” she stated.
“Have been they having a discount in cognitive incapacity and functioning higher? That’s a huge effect for sufferers. And having that sort of information, which we’ve by no means had earlier than, is admittedly impactful.”
Ailani additional famous that migraine is extraordinarily prevalent and that sufferers usually see their major care suppliers first.
“We frequently could have an intuition to offer generic remedies,” she stated.
Nevertheless, she stated, it will be important for clinicians to comprehend that they will first-line prescribe most of the anti-CGRP remedies out there now, even with insurance coverage protection.
“Lots of them will permit it,” she stated. “We’re doing what we are able to to do greatest for our sufferers.”
For extra data:
Jessica Ailani, MD, might be reached at neurology@healio.com.
